Co-Enrolment Guidelines

Interventional clinical trials

STAMPEDE participants should not join any other interventional clinical trials of prostate cancer treatment until the following criteria have been met:

  • The participant has experienced at least one failure-free survival (FFS) event
  • The participant is no longer on any STAMPEDE research treatment that is permitted to continue post first progression e.g. metformin, abiraterone or enzalutamide

Once both criteria are satisfied the participant may be entered into further treatment studies evaluating treatments for CRPC.

Site investigators should check with the CTU prior to participants commencing any IMP within an interventional clinical trial for any other medical condition, such as a new malignancy, to ensure there are no concerns about interactions with STAMPEDE treatments.  Note that STAMPEDE treatment can be continued alongside non-trial treatments for a new malignancy providing local pharmacy review to ensure there are no interactions.

The primary outcome measure of STAMPEDE is overall survival, therefore follow‑up must continue after co-enrolment (unless the participant withdraws consent). Participation in interventional studies must be reported to CTU on the Co-enrolment CRF. Details of any interventional treatments received post-progression in such studies must be reported on the Additional Treatment Log.


Non-interventional clinical trials

Co-enrolment in non-interventional studies for any indication is permitted at any time providing that it does not interfere with treatment or assessment in STAMPEDE. This does not require reporting using the Co-enrolment CRF which captures details of interventional prostate cancer clinical trials only.

Data sharing agreements with “downstream” trials are encouraged to improve data quality in both trials and to reduce costs to both organisations.


Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy

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